Abstract

This is the final version of the guidance document on Regulatory Frameworks for Microbial Biopesticides in Sub-Saharan Africa as commissioned by AATF through the assistance of USDA-FAS. The project to develop this guidance took its origins from an exploratory meeting of relevant stakeholders, in Zanzibar, Tanzania in June 2012 and was thereafter formerly initiated in November of that year, and continued with a meeting to review progress (completion of ‘zero draft’) in Nairobi early in 2013. Subsequent drafts were reviewed by a TWG convened for that purpose by teleconference and email exchanges. The document begins (chapter one) with an introduction that includes background on regulatory principles involved in registration of microbial biopesticides.

Chapter two completes the preliminary part of the guidance by considering how legal form and force could be given to the non-legal regulatory guidance provided. Chapter 3 gives an account of the more practical part of the document including definitions of legal terms, followed by recommended registration procedures for registration authorities (chapter four) and guidance for registrants (chapter 5). An Annotated Bibliography is followed by five annexes with further guidance (annex 1), data requirements, model forms/certificates and other technical details (annexes 2-4), and a checklist for primary law provisions on pesticides (annex 5). The regulatory framework developed was used and ‘road tested’ in a trilateral meeting (Malawi, Mozambique and Zambia) for registration of a microbial biopesticide for aflatoxin control. These three countries are in tier one for adoption of the framework by national authorities but on a harmonised basis. As an outcome of the trilateral meeting an addendum was added on models for harmonised registration of microbial biopesticides. Next steps for wider adoption of the framework at national and REC level are under discussion. Provision is made for the eventual demand for registration of microbial biopesticides that contain genetically modified organisms (GMOs), requiring their approval by the appropriate biosafety regulatory agency in the country of registration. This is the recommended approach towards such products. However, given the sensitivities towards GMOs in some countries, relevant passages are indicated for omission altogether if deemed necessary.